| The Coalition for Hemophilia B is a non-profit organization that does not recommend, endorse or make any representation about the efficacy, appropriateness or suitability of any specific products, procedures, treatments, services, opinions, healthcare providers or other information that may be contained in or available through this email or linked web site. |
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| Used to treat, prevent, or reduce the number of bleeding episodes in people with hemophilia B. See full indication below. |
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| NOW APPROVED FOR ONCE-WEEKLY PROPHYLAXIS |
| Be ready for the unexpected |
| Once-weekly Rebinyn® helps you keep Factor 9 levels higher for longer.a |
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| aRebinyn® achieved and maintained higher factor levels than rFIX based upon a phase 1 study comparing 25, 50, and 100 IU/kg single doses of Rebinyn® to a 50 IU/kg single dose of standard half-life rFIX in 7 adults and a 50 IU/kg dose of plasma-derived FIX in 8 adults. For Rebinyn®, estimated average Factor 9 activity is adjusted to a dose of 50 IU/kg. Incremental recovery at 30 minutes (IR30) and half-life were higher and longer with Rebinyn® than rFIX (IR30 0.0131 vs 0.0068 (IU/mL)/(IU/kg) and half-life 93 vs. 19 hours). The clinical relevance of these PK differences is unknown. Incremental recovery is the increase in plasma concentration per IU/kg of factor administered. Half-life is the time it takes for the level of factor in the blood to fall by half (50%). |
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| Simple once-weekly dosing for routine prophylaxis: |
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| Your doctor may adjust your dosing regimen based on your bleeding pattern and physical activity. |
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| Selected Important Safety Information |
| What is the most important information I need to know about Rebinyn®? |
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Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center. Carefully follow your healthcare provider’s instructions regarding the dose and schedule for infusing Rebinyn®. |
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Who should not use Rebinyn®?
Do not use Rebinyn® if you: |
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are allergic to Factor IX or any of the other ingredients of Rebinyn®. |
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are allergic to hamster proteins. |
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| Please click here or scroll below for additional Important Safety Information. |
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| Maintaining factor levels between doses |
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| The World Federation of Hemophilia (WFH)b says an extended half-life treatment can help individuals to keep Factor 9 levels in the non-hemophilia range (greater than 40%) in between doses for most of the time. |
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| bWFH offers guidelines that inform shared decision-making between patients, caregivers, and healthcare providers based on data from existing peer-reviewed findings. |
| Rebinyn® helps you achieve high factor levels so you can be ready for the unexpected |
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Rebinyn® once-weekly helped previously treated adults spend more time with Factor 9 levels in the non-hemophilia range
(greater than 40%).c |
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| In adults the half-lifee was |
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| In adolescents the half-lifee was |
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| Factor 9 levels after an infusion were 83%, and Factor 9 levels at Day 7 were 24% (n=9)d |
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| cData represent mean steady-state pharmacokinetic profiles from previously treated adolescent/adult patients with moderate to severe hemophilia B (N=9) taking Rebinyn® 40 IU/kg once weekly. Factor 9 levels were within the non-hemophilia range (greater than 40%) for 5.4 days (approximately 80% of the week). |
| dBased on the mean steady-state pre-dose trough levels and post-dose peak levels 30 minutes after infusion in previously treated patients (20 adults and 9 adolescent patients) 168 hours after administered Rebinyn® 40 IU/kg once weekly. |
| eHalf-life: Time required for Factor 9 to decline to half its value. |
| fBased on analysis using a 1-stage assay in patients N=6, age ≥18 the half-life at steady state was 115 hours following once-weekly (40 IU/kg) dosing, in patients N=3, age 13-17 the half-life at steady state was 103 hours. Following single-dose administration (40 IU/kg) in the same patient population, the half-life was 83 hours (adults) and 89 hours (adolescents). |
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| Over 13 years of clinical trial safety data to help you be ready for the unexpected |
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| 115 |
| previously treated patients |
| 292 |
| patient-years of experienceh |
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| 292 |
| patient-years of experienceh |
| 115 |
| previously treated patients |
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| 0 |
| inhibitors or blood clots in previously treated patients |
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You may be at an increased risk of forming blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider if you have chest pain, difficulty breathing, leg tenderness, or swelling. |
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Your body can also make antibodies called “inhibitors” against Factor 9, including Rebinyn®, which may stop Rebinyn® from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time. Formation of inhibitors to Factor IX has occurred following Rebinyn®. |
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Common side effects in previously untreated patients include FIX inhibitors. |
| gAn exposure day is defined as a unit of time (1 day) during which a patient receives factor treatment. |
| h292 patient-years of experience defined as the total number of years all patients have been treated with Rebinyn®. |
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| We’re here to help |
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| Wondering about Rebinyn® or living with hemophilia B? Our Hemophilia Community Liaisons (HCLs) are here to answer your questions and connect you with the resources you need. |
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| Indications and Usage |
| What is Rebinyn®, Coagulation Factor IX (Recombinant), GlycoPEGylated? |
| Rebinyn® is an injectable medicine used to replace clotting Factor IX that is missing in patients with hemophilia B. Rebinyn® is used to treat, prevent, or reduce the frequency (number) of bleeding episodes in people with hemophilia B. Your healthcare provider may give you Rebinyn® when you have surgery. Rebinyn® is not used for immune tolerance therapy. |
| Important Safety Information (Cont’d) |
| What is the most important information I need to know about Rebinyn®? |
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Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center. Carefully follow your healthcare provider’s instructions regarding the dose and schedule for infusing Rebinyn®. |
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| Who should not use Rebinyn®? |
| Do not use Rebinyn® if you: |
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are allergic to Factor IX or any of the other ingredients of Rebinyn®. |
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are allergic to hamster proteins. |
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| What should I tell my healthcare provider before using Rebinyn®? |
| Tell your healthcare provider if you: |
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have or have had any medical conditions. |
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take any medicines, including non-prescription medicines and dietary supplements. |
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are nursing, pregnant, or plan to become pregnant. |
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have been told you have inhibitors to Factor IX. |
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| How should I use Rebinyn®? |
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Rebinyn® is given as an infusion into the vein. |
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Call your healthcare provider right away if your bleeding does not stop after taking Rebinyn®. |
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Do not stop using Rebinyn® without consulting your healthcare provider. |
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| What are the possible side effects of Rebinyn®? |
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Common side effects include infusion site reaction (bruising, bleeding, swelling, pain, or redness), itching, and rash. |
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Your body can also make antibodies called “inhibitors” against Factor IX, including Rebinyn®, which may stop Rebinyn® from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time. |
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Call your healthcare provider right away or get emergency treatment right away if you get, for example, any of the following signs of an allergic reaction: hives, chest tightness, wheezing, difficulty breathing, and/or swelling of the face. |
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You may be at an increased risk of forming blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider if you have chest pain, difficulty breathing, leg tenderness, or swelling. |
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Animals given repeat doses of Rebinyn® showed Polyethylene Glycol (PEG) in certain cells in the brain. The potential human implications of these animal tests are unknown. |
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| Please click here for Prescribing Information. |
Rebinyn® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. |
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| Please do not respond to this email. If you would like to contact us, please click here or call 1‑877‑744‑2579. |
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Rebinyn® is a registered trademark of Novo Nordisk A/S
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2022 Novo Nordisk All rights reserved. US22REB00022 August 2022 |
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